Guardian Technologies' Advances Signature Mapping(TM) Initiatives.HERNDON, Va. -- Guardian Technologies International, Inc. (OTCBB OTCBBSee OTC Bulletin Board (OTCBB). :GDTI), a leading technology developer of intelligent imaging informatics solutions, for the homeland security and healthcare sectors, has completed the first round of clinical evaluations and a series of broad pilot studies involving multi-modalities and multiple diseases. Based on promising internal research and development results, Guardian commenced a broader survey that was designed to evaluate and validate the applicability of Signature Mapping[TM] to the medical imaging applications. A series of broad pilot studies involving multiple modalities and multiple diseases were undertaken through a collaborative effort with the Image Processing and Informatics Laboratory (IPI (Intelligent Peripheral Interface) A high-speed hard disk interface used with minis and mainframes that transfers data in the 10 to 25 MBytes/sec range. IPI-2 and IPI-3 refer to differences in the command set that they execute. See hard disk. ) at the University of Southern California The U.S. News & World Report ranked USC 27th among all universities in the United States in its 2008 ranking of "America's Best Colleges", also designating it as one of the "most selective universities" for admitting 8,634 of the almost 34,000 who applied for freshman admission . IPI provided clinical cases including radiographs with confirmed diagnoses, as well as medical imaging informatics expertise. Clinical study areas and imaging modalities were chosen based upon their ability to provide Guardian broad and deep insight into the capabilities of its core technologies. The initial pilot study chosen was multiple sclerosis (MS), a disease that has been diagnosed in over 400,000 Americans. Healthcare experts believe that over one million people currently live with multiple sclerosis today in the U.S. MS patients undergo multiple MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. scans that require the radiologist to quantify and report any changes to MS lesions over multiple studies and time. This evaluation process is a time-consuming and imprecise activity when performed without the benefits of an automated detection technology such as Signature Mapping[TM]. Results of the MS study found that Signature Mapping[TM] algorithms are capable of accurately detecting lesions and, more importantly, provide accurate measurements of size and overall lesion volumes. Compared to clinical observers, Signature Mapping[TM] proved to be a more sensitive tool for detecting lesions that were considered marginal or undetectable and provided extremely accurate measurements, while reducing the radiologist analysis time to just seconds. Normal pressure hydrocephalus normal pressure hydrocephalus n. A hydrocephalic condition in which the spinal fluid pressure remains normal, resulting from the inability of the arachnoid granulations to absorb cerebrospinal fluid, and characterized by progressive dementia. was also analyzed by IPI. In the normal course of aging the adult brain begins to shrink as a result the internal ventricles Ventricles The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues. which contain cerebral spinal fluid spinal fluid n. See cerebrospinal fluid. begin to enlarge. Enlargement of the ventricles is also associated with numerous anomalies including obstructing tumors. The challenge faced by the radiologist is to determine whether the pressure changes in the ventricles are caused by the normal course of aging or as a result of an anomaly. Signature Mapping[TM] technologies detected and quantified the ventricles and cranial cranial /cra·ni·al/ (-al) 1. pertaining to the cranium. 2. toward the head end of the body; a synonym of superior in humans and other bipeds. cra·ni·al adj. spinal fluid visualized from the MRI images. IPI reviewed the results of utilizing Signature Mapping[TM] and determined the effects to be impressive by demonstrating its ability to detect cerebral spinal fluid, provide a methodology for segmenting the ventricles and determining and quantifying ventricular size and volume. Acute intracranial hemorrhage acute intracranial hemorrhage, n severe bleeding inside the skull. was the third area of application in the brain for Signature Mapping[TM]. This area is of clinical interest due to the large number of intracranial intracranial /in·tra·cra·ni·al/ (-kra´ne-al) within the cranium. in·tra·cra·ni·al adj. Within the cranium. bleeds occurring either due to disease, such as stroke, or from traumatic head injury. There are over 1.5 million traumatic brain injuries in the United States each year. The goal was to develop a Signature Mapping[TM] technology for accurately segmenting and detecting intracranial bleeding using axial Computer Tomography (CT) slices. Cases were categorized into three groups; gross identifiable bleeding, subtle small subdural subdural /sub·du·ral/ (-door´al) between the dura mater and the arachnoid. sub·dur·al adj. Located or occurring beneath the dura mater. bleeds and extremely small subdural bleeds which could be confused with CT bone hardening artifacts artifacts see specimen artifacts. . Signature Mapping[TM] demonstrated in all cases to be an accurate and sensitive tool for the detection of acute intracranial bleeds. It also demonstrated an ability to differentiate between small intracranial bleeds such as less than 5% subdural hematomas and difficult to discern bone hardening artifacts typical in most CT scans. The use of Signature Mapping[TM] to monitor tuberculosis (TB) changes over treated time using radiographic radiographic (rā´dēōgraf´ik), adj relating to the process of radiography, the finished product, or its use. chest x-rays was also studied. Tuberculosis is a serious world health problem; the World Health Organization estimates that over 2 billion people or one third of the world population has or will contract tuberculosis. Tuberculosis is an immune deficiency immune deficiency n. See immunodeficiency. disease and is a complication of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. disease. Tuberculosis is a leading cause of death outside the United States afflicting millions of people in Africa and Eastern Asia. A Signature Mapping[TM] technology was developed to detect lung volume area, quantifying normal lung volume from diseased lung volume and quantitatively report changes in lung volume through drug treatment progress. Signature Mapping[TM] proved to be successful in detecting lung area, quantifying normal lung volumes lung volumes Physiology A group of air 'compartments' into which the lung may be functionally divided Lung volumes Expiratory reserve capacity–ERV The maximum volume of air that can be voluntarily exhaled , and reporting lung volume changes over time during drug treatment therapies. It demonstrated itself to be an excellent tool to aid in quantification and tracking of TB therapy. The last and most difficult area that was evaluated was breast imaging. Two specific challenges are in the areas of image clarification and the clinical interpretation of dense breast digital x-ray examinations. Clinicians at USC An abbreviation for U.S. Code. indicated that as high as 50% of their dense breast tumors could be palpated, but not clearly seen or detected on x-rays. Typically these dense breast areas obscure the visualization of anomalies and potential tumors. Signature Mapping[TM] technology was used to clarify difficult to visualize areas of the breast and to provide improved visualization and detection of tumor areas and edges. Preliminary results suggest a likely opportunity for early detection and mapping of tumors and tumor growth over time. Microcalcifications were easily visualized and demonstrated unique signature responses. Results were extremely encouraging and further clinical study is required. Overall Guardian is extremely excited by its ability to add clinical value to difficult imaging problems in diagnostic radiology. Guardian was able to demonstrate its ability to easily transfer its Signature Mapping[TM] technologies to a new imaging industry application. The Signature Mapping[TM] technologies proved to be an effective tool for detection, segmentation, clarification, quantification and visualization for specifically targeted diseases or anatomical structures. The technology shows broad modality and clinical adaptation for deployment in a wide variety of clinical diagnostic and therapeutic applications. About Guardian Technologies International, Inc. Guardian Technologies International, Inc. (OTCBB:GDTI) employs high-performance imaging technologies and advanced analytics to create integrated information management products and services. Guardian's technologies are focused on two primary markets: Homeland Defense and Healthcare Solutions. For additional information, visit www.guardiantechintl.com. This news release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements in this document and those made from time to time by Guardian through its senior management are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements reflect the Company's current views with respect to the future events or financial performance discussed in this release, based on management's beliefs and assumptions and information currently available. When used, the words "believe", "anticipate", "estimate", "project", "should", "expect", "plan", "assume" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Forward-looking statements concerning future plans or results are necessarily only estimates and actual results could differ materially from expectations. Certain factors that could cause or contribute to such differences include, among other things, in particular, the size and timing of contract awards, performance on contracts, performance of acquired companies, availability and cost of key components, unanticipated results from audits of the financial results of the Company and acquired companies, changing interpretations of generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting , outcomes of government reviews, developments with respect to litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. to which we are a party, potential fluctuations in quarterly results, dependence on large contracts and a limited number of customers, lengthy sales and implementation cycles, market acceptance of new or enhanced products and services, proprietary technology and changing competitive conditions, system performance, management of growth, dependence on key personnel, ability to obtain project financing Project financing A form of asset-based financing in which a firm finances a discrete set of assets on a stand-alone basis. , general economic and political conditions and other factors affecting spending by customers, the unpredictable nature of working with government agencies and other risks, uncertainties and factors including those described from time to time in Guardian's filings with the Securities and Exchange Commission, including without limitation, Guardian's Form 10-K for the year ended December 31, 2005 and its quarterly reports on Form 10-Q. Guardian expressly disclaims any obligation to update any forward-looking statements. |
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